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Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck

20. maj 2014 opdateret af: University of Southern California

Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck

This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of this combination of medications for this type of cancer.

Approximately 54 subjects will take part in this study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • USC/Norris Comprehensive Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection. If it is not available, a repeat biopsy must be performed.
  • Age greater than or equal to 18 years
  • ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 50%)
  • Patients must have adequate organ and marrow function as defined below:
  • leukocytes greater than or equal to 3,000/microliter
  • hemoglobin greater than or equal to 8.0 g/dl
  • absolute neutrophil count greater than or equal to 1,500/microliter
  • platelets greater than or equal to 100,000/microliter
  • total bilirubin within normal institutional limits
  • creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

  • If:

    • ALK PHOS is less than or equal to ULN and AST or ALT is less than or equal to ULN, patient is eligible.
    • ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
    • ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is eligible.
    • ALK PHOS is less than or equal to ULN and AST or ALT is greater than 5x ULN, patient is ineligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is less than or equal to ULN, patient is eligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible.
    • ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 5x ULN, patient is ineligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is less than or equal to ULN,patient is eligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1x but less than or equal to 1.5x, patient is ineligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1.5x but less than or equal to 5x, patient is ineligible.
    • ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 5x ULN, patient is ineligible.
    • ALK PHOS is greater than 5x ULN and AST or ALT is less than or equal to ULN, patient is ineligible.
    • ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is ineligible
    • ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible
    • ALK PHOS is greater than 5x ULN and AST or ALT is greater than 5x ULN, patient is ineligible
  • Patients with neuropathy < 1.
  • Ability to understand and the willingness to sign a written informed consent document
  • Women of childbearing potential must have a negative pregnancy test
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
  • Patients undergoing therapy with other investigational agents.
  • Previous treatment involving regimen utilizing any of the protocol chemotherapeutic agents
  • Patients with known brain metastases
  • History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. Patients with a history of severe hypersensitivity reaction to Taxotere or Oxaliplatin or other drugs formulated with polysorbate 80
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia
  • Pregnant and nursing women
  • HIV-positive patients

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Medicin: Taxotere
Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
Medicin: Oxaliplatin
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tumor Response
Tidsramme: 6 months after the last subject enrolled has gone off study

All eligible patients who received the first dose of Taxotere will be included in the analysis.

Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease.

Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
6 months after the last subject enrolled has gone off study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: At end of every cycle
Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
At end of every cycle

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Southern California

Samarbejdspartnere

Sanofi

Efterforskere

  • Ledende efterforsker: Barbara Gitlitz, MD, University of Southern California

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2004

Primær færdiggørelse (Faktiske)

1. juli 2009

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

12. september 2005

Først indsendt, der opfyldte QC-kriterier

12. september 2005

Først opslået (Skøn)

16. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7H-03-1

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